The Biostatistics Core will serve as a resource for the entire PPG. The goal of the Biostatistics Core is to provide biostatistical collaboration in support of the goals proposed in this program project grant (PPG). The Biostatistics Core will be led by Gregory Wilding, PhD. Dr. Wilding is Vice Chair and Co-Director of the Biostatistics Resource at RPCI and Associate Professor at the University at Buffalo (UB). Specifically, duties of the Core will include 1) assisting in the design, execution and analysis of clinical trials proposed in the PPG; 2) assisting in the establishment of an efficient and reliable mechanism for collection and management of clinical data to facilitate accurate biostatistical analyses and sharing of data among investigators, including implementation of HIPAA compliant processes for data transfer and establishment of guidelines for standards for file and data formats; 3) ensuring that appropriate data are collected; that the data are of the highest quality and meet regulatory standards for privacy; and that the data are those required to answer a study question; 4) assisting in design, analyses and interpretation of correlative studies within the clinical trials and pre-clinical studies proposed in the PPG by applying the appropriate biostatistics analyses, and providing the appropriate interpretation of their results, in terms of both strengths and limitations; and 5) assisting in the preparation of manuscripts and reporting of results. The Core is critical to the attainment of the goal of the PPG and will ensure that the acquired data and conclusions meet strict standards for significance.